title: The Study of the Prevention of Anal Cancer (SPANC): design and methods of a three-year prospective cohort study.
abstract: BACKGROUND
  The incidence of human papillomavirus (HPV)-associated anal cancer is increasing in men who have sex with men (MSM). Screening for the presumed cancer precursor, high-grade anal squamous intraepithelial lesions (HSIL) in a manner analogous to cervical cancer screening has been proposed. Uncertainty remains regarding anal HPV natural history and the role of anal cytology and high-resolution anoscopy (HRA) as screening tests. Well-designed cohort studies are required to address these issues.
  
  
  METHODS
  The SPANC study is a prospective study of the epidemiology of low-risk and high-risk anal HPV infection and related cytological and histological abnormalities in HIV-negative and HIV-positive homosexual men aged 35 years and over. The study aims to recruit 600 men from community-based settings in Sydney, Australia. There are six study visits over three years. At the first five visits men undergo a digital ano-rectal examination (DARE), an anal "Papanicolaou" (Pap) test for HPV detection, genotyping and anal cytology, followed by HRA and directed biopsy of any visible abnormalities. The men also complete a behavioural questionnaire before each visit. Questions include a detailed history of sexual behaviour, of anal symptoms, possible anal cancer risk factors and validated quality of life and psychosocial questions. Questionnaires are also completed 2 weeks and 3 months following the provision of test results and include questions on participant experience during the procedure and post-procedure symptoms, including pain and bleeding in addition to quality of life/ psychosocial outcomes.
  
  
  CONCLUSIONS
  Recruitment for the study began in September 2010 and will conclude in mid-2015, with follow up continuing to 2018. Thus far, over 350 men have been recruited from a variety of community-based settings and are broadly representative of the target screening population. The SPANC study is one of only a small number of cohort studies globally to perform HPV, cytology and HRA screening on all participants over multiple time points. The study results will contribute to understanding of the natural history of anal HPV and inform the possible development of guidelines for implementing anal cancer screening programs in this population.
authors.affiliation: The Kirby Institute, The University of New South Wales, Sydney 2052, NSW, Australia. mpoynten@kirby.unsw.edu.au.
authors.forename: Dorothy A
authors.initials: DA
authors.lastname: Machalek
authors.forename: Andrew E
authors.initials: AE
authors.lastname: Grulich
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Hillman
authors.forename: Fengyi
authors.initials: F
authors.lastname: Jin
authors.forename: David J
authors.initials: DJ
authors.lastname: Templeton
authors.forename: Sepehr N
authors.initials: SN
authors.lastname: Tabrizi
authors.forename: Suzanne M
authors.initials: SM
authors.lastname: Garland
authors.forename: Garrett
authors.initials: G
authors.lastname: Prestage
authors.forename: Kirsten
authors.initials: K
authors.lastname: McCaffery
authors.forename: Kirsten
authors.initials: K
authors.lastname: Howard
authors.forename: Winnie
authors.initials: W
authors.lastname: Tong
authors.forename: Christopher K
authors.initials: CK
authors.lastname: Fairley
authors.forename: Jennifer
authors.initials: J
authors.lastname: Roberts
authors.forename: Annabelle
authors.initials: A
authors.lastname: Farnsworth
authors.forename: I Mary
authors.initials: IM
authors.lastname: Poynten
mesh_terms: D000328:Adult; D001003:Anal Canal / Q000503:physiopathology*; D001005:Anus Neoplasms / Q000175:diagnosis / Q000517:prevention & control* / Q000523:psychology; D002294:Carcinoma, Squamous Cell / Q000175:diagnosis; D055088:Early Detection of Cancer / Q000523:psychology*; D006679:HIV Seropositivity / Q000150:complications; D018451:Homosexuality, Male / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D009517:New South Wales; D027383:Papillomaviridae / Q000302:isolation & purification; D030361:Papillomavirus Infections / Q000175:diagnosis; D011446:Prospective Studies; D011788:Quality of Life; D012107:Research Design; D012307:Risk Factors; D011795:Surveys and Questionnaires; D055815:Young Adult